FDA.reportPublic FDA data

100 ML Flebogamma 50 MG/ML Injection

RxCUI
1809457
RxNorm name
100 ML Flebogamma 50 MG/ML Injection
Display name
100 ML Flebogamma 50 MG/ML Injection
Full name
100 ML Flebogamma 50 MG/ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:52

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125077Flebogamma 5%, Flebogamma 5% DifImmune Globulin Intravenous (Human)351(a)Disc2026-06-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
2cf22c72-64ac-45be-b7c6-d20340730096100 ML Flebogamma 50 MG/ML InjectionSY34These highlights do not include all the information needed to use FLEBOGAMMA 5% DIF safely and effectively. See full prescribing information for FLEBOGAMMA 5% DIF. FLEBOGAMMA 5% DIF (immune globulin intravenous [human]), solution for intravenous administration Initial U.S. Approval: 200620251117
2cf22c72-64ac-45be-b7c6-d20340730096Flebogamma 5 % in 100 ML InjectionPSN34These highlights do not include all the information needed to use FLEBOGAMMA 5% DIF safely and effectively. See full prescribing information for FLEBOGAMMA 5% DIF. FLEBOGAMMA 5% DIF (immune globulin intravenous [human]), solution for intravenous administration Initial U.S. Approval: 200620251117
2cf22c72-64ac-45be-b7c6-d20340730096Flebogamma 5 % per 100 ML InjectionSY34These highlights do not include all the information needed to use FLEBOGAMMA 5% DIF safely and effectively. See full prescribing information for FLEBOGAMMA 5% DIF. FLEBOGAMMA 5% DIF (immune globulin intravenous [human]), solution for intravenous administration Initial U.S. Approval: 200620251117
2cf22c72-64ac-45be-b7c6-d20340730096Flebogamma 5 GM per 100 ML InjectionSY34These highlights do not include all the information needed to use FLEBOGAMMA 5% DIF safely and effectively. See full prescribing information for FLEBOGAMMA 5% DIF. FLEBOGAMMA 5% DIF (immune globulin intravenous [human]), solution for intravenous administration Initial U.S. Approval: 200620251117
2cf22c72-64ac-45be-b7c6-d20340730096100 ML immunoglobulin G, human 50 MG/ML Injection [Flebogamma]SBD34These highlights do not include all the information needed to use FLEBOGAMMA 5% DIF safely and effectively. See full prescribing information for FLEBOGAMMA 5% DIF. FLEBOGAMMA 5% DIF (immune globulin intravenous [human]), solution for intravenous administration Initial U.S. Approval: 200620251117